Medical Device Design Outputs

Quick Overview

This Standard Operating Procedure (SOP) describes the procedures for documenting the Design Outputs corresponding to each Design Input for Product development within the Design Control process. This will also allow for planning of the Verification of the Outputs.

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General

This SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. This Design Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the COMPANY Management approves the initiation of a Product Development Project.